Corcept's Phase 3 Study Shows Lasting Cardiometabolic Benefits of Relacorilant in Hypercortisolism Patients

Corcept Therapeutics Incorporated, a company based in Redwood City, California, has announced promising results from a Phase 3 long-term extension study of its drug relacorilant. The study focused on the treatment of patients with endogenous hypercortisolism, commonly known as Cushing’s syndrome, and was presented at the World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC).

The long-term study involved 116 patients who had earlier participated in Corcept’s Phase 3 GRACE or GRADIENT studies, or its Phase 2 study. Relacorilant is designed to modulate the effects of cortisol, a hormone whose overproduction leads to hypercortisolism. Over a treatment span of up to six years, patients treated with relacorilant showed significant and sustained improvements in cardiometabolic health and the drug was found to be well-tolerated.

Key findings at the 24-month mark of the study included a meaningful decrease in mean systolic and diastolic blood pressure. Specifically, systolic blood pressure was reduced by an average of 10.0 mm Hg, while diastolic pressure was lowered by 7.3 mm Hg. These reductions were statistically significant, with p-values of 0.012 and 0.016, respectively. This improvement was observed using precise 24-hour ambulatory blood pressure monitoring.

Patients who had switched from relacorilant to a placebo during a randomized-withdrawal phase of the GRACE study, and then returned to relacorilant in the extension study, experienced a reversal of any deterioration seen with the placebo and further improvements beyond their initial measurements in the randomized portion of the trial.

Dr. Richard Auchus, a Professor of Internal Medicine at the University of Michigan and Chief of the Endocrinology & Metabolism Section at the Ann Arbor VA Medical Center, presented the study’s findings. He emphasized the risk patients with hypercortisolism face regarding serious cardiometabolic issues, including hypertension and hyperglycemia. He noted that relacorilant offers significant long-term improvements in symptoms without the toxicities associated with existing treatments. The data highlighted progressive reductions in blood pressure, maintenance of cardiometabolic improvements, and the drug’s long-term tolerability.

Bill Guyer, PharmD, Corcept’s Chief Development Officer, pointed out that the positive outcomes from the long-term study echo the findings of prior studies, reinforcing relacorilant’s efficacy and safety. These results are set to support the submission of a new drug application for relacorilant, which the company plans to file shortly. Guyer expressed confidence in relacorilant’s potential to become a new standard of care for individuals with hypercortisolism.

Relacorilant is a selective cortisol modulator that targets the glucocorticoid receptor without affecting other hormone receptors in the body. Besides its application in treating Cushing’s syndrome, Corcept is exploring relacorilant’s potential use in treating other serious conditions, such as ovarian, adrenal, and prostate cancers. The drug holds orphan drug designation in both the United States and the European Union specifically for addressing Cushing’s syndrome, which is characterized by symptoms like high blood pressure, central obesity, elevated blood sugar, and severe fatigue.

For over two decades, Corcept Therapeutics has been at the forefront of developing selective cortisol modulators, exploring their potential to address a variety of severe health disorders. The company has made significant strides in clinical trials across diverse conditions, including hypercortisolism, solid tumors, ALS, and liver disease. In 2012, Corcept's drug Korlym was the first to receive FDA approval for the treatment of endogenous hypercortisolism, marking a significant milestone in the company’s commitment to advancing treatments for this disorder.